Valproate sodium and Gastrointestinal haemorrhage - a phase IV clinical study of FDA data


Gastrointestinal haemorrhage is found among people who take Valproate sodium, especially for people who are female, 60+ old, have been taking the drug for 1 - 6 months.

The phase IV clinical study analyzes which people take Valproate sodium and have Gastrointestinal haemorrhage. It is created by eHealthMe based on reports of 19,507 people who have side effects when taking Valproate sodium from the FDA, and is updated regularly. You can use the study as a second opinion to make health care decisions.

Phase IV trials are used to detect adverse drug outcomes and monitor drug effectiveness in the real world. With medical big data and AI algorithms, eHealthMe is running millions of phase IV trials and makes the results available to the public. Our original studies have been referenced on 600+ medical publications including The Lancet, Mayo Clinic Proceedings, and Nature.

On Dec, 20, 2022

19,507 people reported to have side effects when taking Valproate sodium.
Among them, 56 people (0.29%) have Gastrointestinal haemorrhage.

What is Valproate sodium?

Valproate sodium has active ingredients of valproate sodium. It is often used in epilepsy. eHealthMe is studying from 20,048 Valproate sodium users for its effectiveness, alternative drugs and more.

What is Gastrointestinal haemorrhage?

Gastrointestinal haemorrhage (bleeding gastrointestinal tract) is found to be associated with 2,499 drugs and 1,968 conditions by eHealthMe.

Number of Valproate sodium and Gastrointestinal haemorrhage reports submitted per year:

Could Valproate sodium cause Gastrointestinal haemorrhage?

Time on Valproate sodium when people have Gastrointestinal haemorrhage *:

  • < 1 month: 27.27 %
  • 1 - 6 months: 45.45 %
  • 6 - 12 months: 18.18 %
  • 1 - 2 years: 9.09 %
  • 2 - 5 years: 0.0 %
  • 5 - 10 years: 0.0 %
  • 10+ years: 0.0 %

Gender of people who have Gastrointestinal haemorrhage when taking Valproate sodium *:

  • female: 52.73 %
  • male: 47.27 %

Age of people who have Gastrointestinal haemorrhage when taking Valproate sodium *:

  • 0-1: 0.0 %
  • 2-9: 0.0 %
  • 10-19: 14.89 %
  • 20-29: 12.77 %
  • 30-39: 10.64 %
  • 40-49: 19.15 %
  • 50-59: 4.26 %
  • 60+: 38.3 %

Common drugs people take besides Valproate sodium *:

  1. Lorazepam: 8 people, 14.29%
  2. Clozaril: 7 people, 12.50%
  3. Lamotrigine: 7 people, 12.50%
  4. Fluoxetine: 6 people, 10.71%
  5. Olanzapine: 6 people, 10.71%
  6. Tacrolimus: 5 people, 8.93%
  7. Phenytoin: 5 people, 8.93%
  8. Methotrexate: 5 people, 8.93%
  9. Lansoprazole: 5 people, 8.93%
  10. Clonazepam: 5 people, 8.93%

Common side effects people have besides Gastrointestinal haemorrhage *:

  1. Multi-Organ Failure (multisystem organ failure): 9 people, 16.07%
  2. Acute Kidney Failure: 8 people, 14.29%
  3. Haemoglobin Decreased: 8 people, 14.29%
  4. Diarrhea: 7 people, 12.50%
  5. Malaise (a feeling of general discomfort or uneasiness): 7 people, 12.50%
  6. Disseminated Intravascular Coagulation (systemic activation of blood coagulation): 7 people, 12.50%
  7. Rhabdomyolysis (a condition in which damaged skeletal muscle tissue breaks down): 6 people, 10.71%
  8. Hypotension (abnormally low blood pressure): 6 people, 10.71%
  9. Toxic Shock Syndrome (a rare but serious medical condition caused by a bacterial infection): 5 people, 8.93%
  10. Drug Ineffective: 5 people, 8.93%

Common conditions people have *:

  1. Schizophrenia (a mental disorder characterized by a breakdown of thought processes): 9 people, 16.07%
  2. Convulsion (muscles contract and relax rapidly and repeatedly, resulting in an uncontrolled shaking of the body): 8 people, 14.29%
  3. Schizoaffective Disorder (a mental disorder characterized by disordered thought): 5 people, 8.93%
  4. Acute Promyelocytic Leukaemia (cancer of the blood and bone marrow): 2 people, 3.57%
  5. Oedema (fluid collection in tissue): 2 people, 3.57%
  6. Head Injury: 1 person, 1.79%
  7. Affective Disorder (mental disorder): 1 person, 1.79%
  8. Artery Dissection: 1 person, 1.79%
  9. Atrial Fibrillation/flutter (atrial fibrillation and flutter are abnormal heart rhythms in which the atria, or upper chambers of the heart, are out of sync with the ventricles): 1 person, 1.79%
  10. Bipolar I Disorder (mood disorder that is characterized by at least one manic or mixed episode): 1 person, 1.79%

* Approximation only. Some reports may have incomplete information.

Do you take Valproate sodium and have Gastrointestinal haemorrhage?

Check whether Gastrointestinal haemorrhage is associated with a drug or a condition

How to use the study?

You can discuss the study with your doctor, to ensure that all drug risks and benefits are fully discussed and understood.

Related publications that referenced our studies

Related studies

How severe was Gastrointestinal haemorrhage and when was it recovered:

Expand to all the drugs that have ingredients of valproate sodium:

Alternative drugs to, pros and cons of Valproate sodium:

Common Valproate sodium side effects:

Browse all side effects of Valproate sodium:

a b c d e f g h i j k l m n o p q r s t u v w x y z

Gastrointestinal haemorrhage treatments and more:

COVID vaccines that are related to Gastrointestinal haemorrhage:

Common drugs associated with Gastrointestinal haemorrhage:

All the drugs that are associated with Gastrointestinal haemorrhage:

Common conditions associated with Gastrointestinal haemorrhage:

All the conditions that are associated with Gastrointestinal haemorrhage:

How the study uses the data?

The study uses data from the FDA. It is based on valproate sodium (the active ingredients of Valproate sodium) and Valproate sodium (the brand name). Other drugs that have the same active ingredients (e.g. generic drugs) are not considered. Dosage of drugs is not considered in the study.

Who is eHealthMe?

With medical big data and proven AI algorithms, eHealthMe provides a platform for everyone to run phase IV clinical trials. We study millions of patients and 5,000 more each day. Results of our real-world drug study have been referenced on 600+ medical publications, including The Lancet, Mayo Clinic Proceedings, and Nature. Our analysis results are available to researchers, health care professionals, patients (testimonials), and software developers (open API).


WARNING: Please DO NOT STOP MEDICATIONS without first consulting a physician since doing so could be hazardous to your health.

DISCLAIMER: All material available on is for informational purposes only, and is not a substitute for medical advice, diagnosis, or treatment provided by a qualified healthcare provider. All information is observation-only. Our phase IV clinical studies alone cannot establish cause-effect relationship. Different individuals may respond to medication in different ways. Every effort has been made to ensure that all information is accurate, up-to-date, and complete, but no guarantee is made to that effect. The use of the eHealthMe site and its content is at your own risk.

If you use this eHealthMe study on publication, please acknowledge it with a citation: study title, URL, accessed date.

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